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U.S. Department of Health and Human Services

Class 2 Device Recall Niobe ES

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  Class 2 Device Recall Niobe ES see related information
Date Initiated by Firm September 21, 2020
Create Date November 06, 2020
Recall Status1 Terminated 3 on November 13, 2023
Recall Number Z-0430-2021
Recall Event ID 86555
510(K)Number K192775  
Product Classification Catheter remote control system - Product Code PJB
Product Niobe ES System, Models 001-006000-1 and 001-006100-1
Code Information Devices with the following system numbers (serial): 105, 108, 113, 116, 124, 125, 126, 128, 130, 131, 134, 135, 138-142, 144, 147, 149, 154, 158, 162, 163, 169, 170, 172-174, 177-179, 181-183, 185, 187, 189, 190, 192-202, 205, 206, 208-210, 212, 214-222, 224-229, 231, 232, 235-242, 244, 245, 249, 251-256, 258-278, 280-284, 286, 287, 288, 290, and 297
Recalling Firm/
Manufacturer		 Stereotaxis Inc
4320 Forest Park Ave Ste 100
Saint Louis MO 63108-2979
For Additional Information Contact Adam Miller
314-678-6100
Manufacturer Reason
for Recall		 There is a potential for fire in the inside computer cabinet.
FDA Determined
Cause 2		 Device Design
Action The firm will be contacting consignees via email and providing an electronic Urgent Field Safety Notice and Customer Reply Form. Consignees are asked for return the acknowledgement form to the firm within 30 days of receipt.
Quantity in Commerce 121
Distribution US and OUS distribution: US - TN, MI, MN, KY, MO, IN, TX, NM, CA, NE, OH, NJ, CT, KS, OR, WA, WI, FL, IL, UT, PA, AZ, NY, GA, ID, OK, CO, LA OUS - EU, China, Australia, Singapore, Canada, South Africa, and Japan
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PJB and Original Applicant = Stereotaxis, Inc.
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